Part Two: The Food And Drug Administration

Robert is again joined by Matt Lieb to continue to discuss the Food And Drug Administration.

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Episode Transcript

Speaker 1 (00:02):
Welcome back to Behind the Bastards, the only podcast with
more worms than the average bottle of milk in a
century ago. Tougs of worms and filled with them. Love
your new tagline. It's great, thank you, thank you. It's
We're gonna move on from discussing horrible old timey foods

(00:24):
before there were any kind of laws about what you
could do with foods. But I just came across an
article in the Guardian. Uh, you know there's that truck
convoy trying to do with January six in Canada all
about next week. Yeah, there's an article in the Guardian
called Canada trucker's vaccine protests spirals into calls to repeal
all public health rules. My favorite, my favorite response on

(00:47):
Twitter is someone who's posted a picture of a sign
outside of a swimming pool that says person is currently
having active diarrhea or who have had active diarrhea within
the previous fourteen days shall not be allowed to enter
the pool water. And he's just responded, He's just most
of that and said in all caps, oh, captain, my captain.
This concludes the part of the episode where I read

(01:09):
to you from Twitter, mad, what you you got a
podcast compare yourself a gun but yourself a gun past.
It's uh. You know, this is what separates us from
any other TV rewatch podcast as uh I do a
parody song every week that does the synopsis of the episode.
Is it good kind of tow? People like it? Oh? No,

(01:32):
do I do it? Yes? Insistently? U what a plug?
Everyone loves that hot damn Matt. Now now that we
have really we've laid the groundwork here, it is time
to move on to the true bastard of our episode,
the f d A. We've had it's it's it's Anakin

(01:52):
Skywalker phase here and now we're about it's about to
go full Vader, right, That's that's today's story. Pub poisoned
back in the food Yeah, actually, yes, that is a
part of what's happening in this period. Um, of course,
it is much bigger than that. We're actually going to
focus a bit more in the pharmaceutical industry today. There's
a lot to say about food though. So we ended

(02:14):
last episode with the creation of the f d A
in nineteen thirty eight, after eight years after the death
of Harley Whitley. Harvey Whitley, he dies in nineteen thirty uh.
And the FDA was initially taxpayer funded. Right again, so
all of its money at first comes from the American
people because its job is to be a watchdog for
the American people and to make sure they're eating. That's changed. Oh, yes,

(02:36):
that's a big part of our story today, Matt. So
at first it is taxpayer funded, and as a taxpayer
funded organization, it experiences a titanic success very early on.
When we've actually discussed previously on the show. In the
late nineteen fifties, the grun in Tall Corporation of Germany,
which was a pharmaceutical concern staffed mainly by Nazis, tried

(02:58):
to get approval to sell their blockbust a new sleeping pill, philidamide,
which may have initially been tested on concentration camp inmates
in the United States now for the person and it
was like some other company that was trying to sell
the product for gruden Tal was buying and wanted to
sell in the U S. Whatever, Like you know, corporations work.
But this company that wants to sell palidamide in the
U s as a sleeping pill, UH, has to go

(03:20):
to the FDA to get approval, right, and the person
they come before is Francis Oldham Kelsey. Now Francis Kelsey
had earned a PhD the same year the FDA was founded,
and she had been hired in nineteen sixty after six
years of teaching pharmacology at the University of South Dakota.
Um So, her job, she's one of the people who's
supposed to evaluate new medical sins and substances and decide

(03:41):
whether or not they get FDA approval. One of her
very first assignments for the FDA was the litamide and
her job is essentially to review the evidence of drug
safety provided by the manufacturer, because that's what that nineteen
thirty eight law, in the nineteen o six law had
gradually established that if you want to sell a medicine,
you have to prove it works and that it doesn't
kill people, or at least it doesn't kill too many people, right,

(04:02):
any kind of effect. Yeah, you have two shows. You
have to prove it alike, be worth it, you know.
Um So, it's her job to review all of that evidence. Now,
Solidamite is at this point in use in like forty
six nations around the world, including most of Europe. But
Dr Kelsey thought their data was shipped. She actually looks
at the evidence they have that this stuff is safe,
and she's like, because one of the big things they're

(04:23):
selling this as is it's like this is finally a
safe sleeping pill for pregnant women, right, and they're they're
saying that based on nothing, and in fact, a lot
of the data they have suggests that, like, no, it's
actually like it's fine for women who are nursing. They
do show that that, like, it's probably okay for women
who are nursing to have it, but there's there's evidence
that it's really bad for pregnant women. Um, and there's

(04:43):
really tried out and Nazi concentration camps. Well, that is debatable.
We talked about this in the episode. Yeah, there's a
lot of evidence that suggests that it's not ironclad. So
I don't want to be like saying, but there is
some evidence that's because they were they were Nazi doctors
who were in concentration camps are the people who are
doing all of the medical testing for Grooon at all,

(05:04):
and there's evidence that they just like took this drug
they've been testing in camps and like tried to launder its. Robert,
I'm not about nuance. We're gonna call it anti semitic
ambient and anti semitic ambient. That's right. So anti semitic
ambient is in use all over the world. Um. But
Francis Kelsey is like, I don't give a shit about
what the rest of the world says. This data doesn't
convince me, and it's my job to say whether or

(05:26):
not this ship is safe, So I don't give you approval. UM.
So she turns them down, and then they try to
pressure her boss, and her boss backs her to the hilt.
Her boss is like, no, Frances is fucking great scientist,
and she's right about this, and we're not gonna fucking
self phillidamite in the United States, and the litamite has
never approved for use on a wide scale in the
U S. There's a couple of like trials and stuff.

(05:49):
A handful of Americans do take it um, but nothing
like what happens in Europe, where millions of people take
the litamide. Roughly one year after she turns down philidamide,
scientists and Urbany and Australia proved that the litamide caused
a whole host of debilitating birth defects. Babies were being
born without lungs or with their arms coming directly out
of their shoulders and like no actual like like foe

(06:11):
arms and ship. You can find pictures if you want.
Tens of thousands of children are disabled, hundreds of thousands
of children that are disabled, Tens of thousands are killed
as a result of the litamide. Um, but none of
those are in the US, thanks to Dr Kelsey and
the f d A. This is a huge success. Is
exactly what it's there for, right, that's for this is
a bullet proof vest stopping a bullet from entering your body.

(06:32):
This is like exactly why we have this thing in
proof that it is worth every goddamn penny. Um. And
Americans at the time recognize that they have dodged a
huge bullet. H The ship that happens with the litamide
inspires the passage of the nineteen sixty two Drug Amendments.
This bill is why ads for new medicines always end
with like forty seconds of a dude talking very fast

(06:54):
about the side effects experience. Like that's that's where that starts,
like being mandatory, right, um, And there's a bunch of
other good stuff and it including it forces a comprehensive
reclassification of all available drugs based on whether or not
they actually do anything. So there were all this medicine
that was like grandfathered in when the FDA gets created,
and they're right, well, actually, why the funk are we
doing that? We should make sure this stuff all works.

(07:15):
You know, I don't care we got tested. I understand
that dark defeats the bright, but we gotta test it.
I'm not a big law fan, but the nineteen sixty
two drug ammendments are pretty comprehensively, like a good, good,
good call, you know. Um So, the f D a
huge fucking hit at this point, right, Like, that's that's

(07:36):
I mean, that's worth all the money we'd spent on
it forever if they just stopped the litamide. And obviously
there's other ship they're stopping their ship they're making safer.
There's stuff that they're you know, medications that they're limiting
the scope of that too many people don't take them.
The FDA is doing fucking gang busters, and it's it's
first few decades in existence. Um So, that's dope as hell.
And President Kennedy even gives the agency a shout out

(07:58):
in nineteen sixty two shortly but or being gunned down
by Bernard Montgomery Sanders. And it's worth noting that this
massively but I mean, okay, look, there is the theory
that Orenthal James Simpson, who was a young adult at
this period of time, may have taken part in the
assassination of John Fitzgerald Kennedy. He was a very fast runner.

(08:20):
I believe that he may have been providing the ammunition
to Bernie Sanders. Um, there's no way to know that
he wasn't you know. That's why proved me wrong. Yeah,
what are you gonna do? Show me that Bernie Sanders
and O J and the Juice didn't collaborate together to
assassinate John Fitzgerald Kennedy. Prove it. I hope that we
all did a headshake in Unison when that happened. So

(08:46):
it's worth noting that this, uh, this, this massive early
dub for the f d A was due in part
to the agency's independence in large part. Really like the
fact that this this is there's no ties to anybody
but the U. S. Taxpayer. That is the only response
posibility the f d A has. There's a shipload of
money to be made in approving like philidamide right, Like

(09:06):
they could have been like that, Like that company would
have made millions before they realized that it was harming
babies at a scale almost inconceivable. But the only FDA
doesn't give a shit about anybody's profits. All they care
about his safety. And Dr Kelsey looked at the data
and was like, no, funk, this ship responsible only to
the taxpayers, because that's what government is supposed to do. Well,

(09:28):
that's not how the FDA works anymore. Um. And to
explain why things changed, I'm going to read a quote
by a write up from Michael White of the University
of Connecticut School of Pharmacy. Quote. The first US case
of HIV induced AIDS occurred in nineteen eighty one. It
was rapidly spreading, with devastating complications like blindness, dementias, severe
respiratory diseases, and rare cancers. Well known sports stars and

(09:51):
celebrities died of AIDS related complications. AIDS activists were incensed
about long delays and getting experimental HIV drugs studied and
approved by the f d A. In nineteen nine two,
in response to intense pressure, Congress passed the Prescription Drug
User Fee Act. It was signed into law by President
George H. W. Bush. With the Act, the FDA moved
from a fully taxpayer funded entity to one funded through

(10:13):
tax dollars and new prescription drug user fees. Manufacturers pay
these fees when submitting applications to the FDA for drug review,
and annual user fees based on the number of approved
drugs they have on the market. Now surface level go
back in time. Number one. This is in response to
a real problem, right, the and this we saw this

(10:33):
with like COVID. Right, sometimes you can't afford to take
as much time, you know, testing ship because there's a
real immediate fucking plague and you might just need to
like throw some ship out there. And maybe there will
be some side effects with the boosters and ship I.
You know, some people like there are some side effects
and ship um that we probably would have caught and
maybe even minimized if we had not been dealing with

(10:55):
a global play, right, Like you gotta fucking get shipped out.
You know, that's a reasonable problem. The way they one
of the ways they deal with this is that like
they make this partially funded by the pharmaceutical drug companies,
and they allow ways for the FDA to expedite um
pharmaceutical drug approvals. And this is where all the problems

(11:15):
start to come in. Right, But you have to note
that it does kind of sound surface level reasonable to
a lot of people. And this is kind of the
way a lot of the government works really. Right, you
go to the d m V. You have to pay
fees to apply for stuff, right to get like register
a car, get a license. Why wouldn't big pharmaceutical companies
have to pay the FDA for drug review and other stuff?
You know, you can make a case to most people
on both sides of the political spectrum that this is

(11:38):
a reasonable idea, right um. And obviously the reason why
you don't do that for the f d A is
because it might lead to a situation wherein those companies
are all paying the FDA for the FDA to exist.
And when the people funding your organization are the folks
with a vested interest in you saying yes to their drugs, well,
that can cause some problems. You are no longer the

(11:58):
independent organization that stopped philetamide from hitting the streets. You
know it was there was a short sighted move on
that law. You know, I got where they were coming
from But uh, it sounds bad. You get why people
could be convinced that this was a good idea because
it sounds like a tax. It sounds like, Oh, all
we're doing is like making you know, you're you're still

(12:19):
going to get the money from the taxpayers, but you're
also we're gonna a tax these companies for you even applying.
And it's like it is tying these salaries of uh,
the of of the people who work for the FDA
to the pharmaceutical industry. You know, that's that's what it's doing,
and that's not great, you know. Um So, over the years,

(12:43):
new fees were introduced for the approval of generic drugs,
over the counter drugs, biosimilar drugs, animal medications, as well
as medical devices. The FDA develops a complex system of waivers, refunds,
and exemptions dependent on the category of drug and the
total number of drugs the manufacturer had approved. A LABYRINTHI
an expensive bureaucracy developed, and the proceeds from this bureaucracy

(13:03):
grew to account for forty of the f d a's
five point nine billion dollar budget. But wait, there's more.
Sixty five percent of the funding for human drug regulation
comes directly from user fees submitted by pharmaceutical companies. Now
this has had some positive outcomes because their funding comes
from these fees. The FDA has gotten a lot faster

(13:24):
at responding to manufacturers about what they need in their applications.
The whole process of getting new medicines approved has gotten
a lot speedier. Seven it took twenty nine months to
get FDA approval or denial. By fourteen, it took thirteen months.
By two eighteen, it was down to ten months. President
Trump personally promised to streamline the process by which drugs
were approved, and his administration seems to have delivered in

(13:47):
this respect. Now that can be good, as we've seen
in the COVID responses. Sometimes you need stuff approved very rapidly,
but usually you don't. One of the things that these
changes have done is they've led to an increase from
thirty eight percent to sixty one in the number of
first time approvals on new drug applications in diseases where

(14:07):
there are a few existing medications and even more streamlined
approval process means that eight nine percent of applications get
approved the first time, often and under eight months. This
is all coincided with a huge surge in the number
of new drug applications because you can get them said
yes a lot quicker and get him out there and
start making fucking money. So that is impressive if you
don't account for the fact that an awful lot of

(14:28):
these new drugs getting expedited approvals are fucking horrible. And
I'm gonna quote from Michael White from the University of
Connecticut here. While the number and speed of drug approvals
have been increasing over time, so have the number of
drugs that end up having serious safety issues coming to
light after FDA approval, and one assessment, investigators looked at
the number of newly approved medications that were subsequently removed

(14:48):
from the market or had to include a new black
box warning over sixteen years from the year of approval.
These black box warnings are the highest level of safety
alert that the FDA can employ, warning users that are
very serious verse event could occur before the user fee
was approved of medications were removed or had new black
box warnings as compared to twenty seven percent afterwards. Now

(15:09):
that jump alone is not great, right, but it's also like,
you know, six percent, that's not the worst thing in
the world, But when you really dig into the data,
it's it sounds a lot worse than that. Actually, matt um,
it does. It does. And I'm gonna quote now from
a write up I found by CNN, about a third
of the drugs the FDA approved between two thousand and
one and two thousand ten were involved in some kind

(15:29):
of safety event after reaching the market, According to a
study published in Tuesday in the Journal of America the
American Medical Association. The authors found that in that time,
two and twenty two novel therapeutics were approved, and there
were a hundred and twenty three post market safety events
involving seventy one products that required FDA action. Manufacturers needed
to add sixty one boxed warnings also commonly called a
black box warning to call attention to serious risks. In

(15:52):
fifty nine cases, some communication had to warn the users
about a product safety. Three therapeutics were withdrawn from the market. Now,
remember how I said that the FDA expedites approval requests
for drugs to treat illnesses where there aren't a lot
of existing treatments. That's good again, if there's like a
plague or something that you need to get out quick,
but it also means there's an extra financial incentive for

(16:13):
a pharmaceutical corporation to get a medicine approved to treat
an illness that doesn't have a lot of medicines for it.
This includes all of the mental illnesses, right, yeah, really
shortage of medicines because maybe in a lot of cases
medicines don't help that much. With a lot of studies,
we're fighting not not to be against medications. A lot
of great medications out there, but there's a lot of
fucking problems with mental health medications, and it's very fucking

(16:35):
easy to get an approval for a mental health medication. Um.
And that for a while, mental health medication was just
doing electricity on your brain. So you know, at this point,
if it's in pillform, people are like, yeah, proven you
don't you would think that it wasn't worse now, but
in some ways it is. Um so that a m

(16:57):
A journal report noted that drugs used for mental illness
had a higher number of events UM like negative health
and safety events. And most of these drugs, and most
of accelerated drugs are approved on trials with fewer than
a thousand patients. Because the bar is lower, they don't
need to show that it works on many people. If
you can jig a trial with a hundred people with
a thousand people and show that it works like five

(17:18):
people or whatnot, you can fucking get approval and expedited
as well. Yeah, yeah, you can get it done really quickly.
And there's a good book. We're not going to get
into it much because I'm kind of focusing on the FDA.
There's a whole book written about all of the different
ways in which the the medical testing industry, like the
industry that is designed to determine whether or not drugs work,

(17:40):
is heavily compromised because most of those studies are funded
by the pharmaceutical companies. There's all sorts of ways they
funk with the data. A lot of those scientists wind
up getting like cushy jobs afterwards and stuff with these companies.
There's all sorts of ways like that's a big part
of how a lot of very like negative like that's
how they That's how a lot of like negative aspects
of different foods like sodas and ship get hidden for

(18:03):
so long. Because you can kind of have a study
of five people that you control, and you can make
it kind of say whatever you want. The book is
called Unsavory Truth, How Food Companies skew the science of
what we eat, and it includes a lot of detail
on the pharmaceutical industry to It's by a woman named
Mary and Nestleie no relation to the candy people. Um again,
we're not really going to get into that, but yeah,

(18:25):
I I should, you know, I should read one quote
from this about the way in which industry funded research
favors the sponsors commercial interests. So I'm gonna read a
quote from that book here. Sheldon Crimsky, a Toughs University
professor who studies industry manipulation of science, dates the discovery
of this funding effect to the mid nineteen eighties, when
social scientists realized that if they knew who paid for

(18:45):
a study, they could predict its results. One funding effect
investigation from the late nineteen nineties looked at studies on
the safety of calcium channel blockers for reducing blood pressure.
Nearly all authors nineties percent who concluded that the drugs
were effective, reported financial ties to their manufactures. Only thirty
seven percent of authors who doubted the effectiveness had such ties,
and two thousand three a systemic review of more than

(19:06):
one thousand biomedical research studies came to a similar conclusion.
Investigators with industry affiliations were nearly four times more likely
to come up with pro industry conclusions than those without
such ties. See, that's why we don't trust doctors. If
you want to know why they're there's a reason people
are so distrustful about like the vaccines in the medical industry.
Like they should be distrustful, just not in this specific case. Really, yeah,

(19:31):
I mean, it's just it sucks because it's like every
time I hear an anti vaxer talk, I'm always like,
there's part of me that understands exactly where you're coming from,
minus the part where you're completely ignoring all subsequent data
as to the efficacy of these like vaccines. But it's
like I get it because like, yeah, nine out of

(19:52):
ten doctors think that this drug is good. Also, nine
out of ten doctors are paid for by the company
that makes this drug. It's just yeah, maybe a better
solution would be to tax all of the billionaires until
they're not billionaires, to dissolve all pharmaceutical corporations, and to
take all of their patents and property and money and
put it in a trust run or administered by, you know,

(20:13):
an agency made up of scientists who are purely paid
and supported by the taxpayer, whose job is to make
pharmaceutical stuff happen. Maybe just off the topic I did
I I I've actually invented a whole system. Um it's
called Marxist uh Robertism. Yeah, that's that's that's very heavily

(20:35):
based on what I what I another word, I invented socialism. Yeah. Yeah,
I'm the first person to figure this out. I have
a lot of great ideas. We're going to freeze a
lot of seeds to see if it makes them cold tolerant,
a lot of cool stuff. Try that out. Try that yeah.

(20:59):
So uh yeah, one area where all of this ship.
Uh this uh horrific. But so and again it's like
one of those the basic idea by which this problem
started as like reasonable, Well, these companies should have to
prove their medicine works. They should be conducting studies to
show that the stuff is safe and that it does
what it says it does. Very reasonable thing to propose

(21:22):
in like nineteen when it is like pushed. But you
see the obvious problem, which is that, well, they're not
gonna fun to study because they care so much, because
their primary interest is profit, their primary interest is not
helping people. A lot of the doctors and stuff, their
interest is helping people. And like one of the things
that I will say, a lot of those people who
those scientists whose results are heavily skewed by the fact

(21:43):
that they're being paid by pharmaceutical companies. It's not because
they're like evil or even know what they're doing. It
just happens. Um. It's likewise, I don't talk about the
fact that has an island where they allow you to
hunt children for sport very often. You know, um, because
I'm swimming in those bucks. Baby, you're just filled with
Salisbury steaks that you're gonna cook fresh tonight. They stakes

(22:06):
made from the children hunted on their private island. You know,
it's good stuff. You taste the fear, you know. So
one area where this whole problem may have had a
major impact both the fact that they're conducting the industry
is conducting these studies, um, and that this approval process
it's a lot easier to get mental health medication approved
is in the treatment of schizophrenia. In recent years, the

(22:27):
World Health Organization has released two studies which find that
long term outcomes for schizophrenia patients in three developing countries.
This is the term that they use. I don't prefer
that term, but I'm reading from a study they did
so skip long term outcomes for schizophrenia patients and three
developing countries were actually better than in the United States
and five other developed countries. Now, why how can this be? Well,

(22:52):
it's not entirely known, but one probably the leading theory
is that the countries with better outcomes for treating schizophrenia
only used anti psychotic meds acutely, not chronically. So they
give people They're not like rejecting this medication, but they
use it when someone is having an issue, when they're
having a psychotic breakers and not daily. You know. Um,

(23:15):
only sixteen percent of patients in those countries were on
regular maintenance doses of antipsychotics. Is supposed to basically everybody
with schizophrenia in the United States, right, That is the
standard of care um for most people who are dealing
with that here. And we have worse outcomes in these
countries with a lot less money to spend on their
medical system, and that maybe why. A subsequent Harvard study

(23:35):
found that schizophrenia outcomes for patients in the United States
have declined over the last twenty years, and at present
they are no better than they were in the nineteen twenties.
Fuck like the electrocution days, right Like, we've gone back.
We had gotten a lot better for a while, but
we we've gone back. Um journalist Robert Whittaker has investigated
the subject heavily, and he puts blame on a shamefully

(23:56):
lax testing process for medication for schizophrenia, the result of
all of the systems we've just discussed. Quote. When you
look at the short term studies of antidepressants and antipsychotics,
the evidence of efficacy in reducing symptoms compared to placebo
is really pretty marginal and fails to rise to the
level of a clinically meaningful benefit. Furthermore, the problem with
all of this research is that there is no real

(24:18):
placebo group in the studies. The placebo group is composed
of patients who have been withdrawn from their psychiatric medications
and then randomized to placebo. Thus, the placebo group is
a drug withdrawal group, and we know the withdrawal from
psychotic drugs can stir myriad negative effects a medication naive
placebo group would have a much better outcome. In short,
the research on the short term effects of psychiatric drugs

(24:40):
is a scientific mess. In fact, a two thousand seventeen
paper that was designed to defend the long term use
of antipsychotics nevertheless acknowledged in an off hand way that quote,
no placebo controlled trials have been reported in first episode
psychosis patients. Antipsychotics were introduced sixty five years ago, and
we still don't have good evidence that they work over
the short term in first episode patients. Still still it's

(25:05):
it's it's a very unlike you dig into it, it's
very messy. I should note there are researchers and scientists
who criticize Whittaker's work. Here one of the reasons I
tend to trust him number one, there's other experts that
back him. Number two. When he's interviewed by I found
this in a Scientific American article. He linked lists lengthily
all of the different criticisms of his work, and he
links to responses he's made to all of them, and

(25:26):
he points out the ones I think these have some
these guys have some points. I think these guys are
fascile you know. One of the reasons that I tend
to think he's probably onto something, um, because he actually
addresses the criticism and has rebuttals to it. Yeah, Yeah,
he's he's taking it seriously as as scientists as opposed
to like going for you know the thing um, And

(25:47):
his arguments feel extracredible to me because the same sorts
of problems that he outlies are in dimmick when you
look at other major failures of the f DA. So
it's not just with these medications he's criticizing. It happens
all over the goddamn time, um. And a strong argument
could be made that if the lidamide came before the
FDA Approval Board today, it probably would have wound up
in pharmacies across the country because there were no sleeping

(26:09):
medications that were safe for pregnant women. And if the
lidamide is able to get like a thousand person study
that kind of sort of shows that then yeah, then
suddenly boom, we've got a lot of philidamite up in air,
you know study and uh all know those babies who's
like arms are on their legs and legs on their arms,
that's actually just that's like part of it. They like
to They like that. Everybody likes that. Ye helps, Mr

(26:32):
just holding you back? Yeah exactly, it's trust me, dude,
he's into it. We're all we're Mr Potato heading on.
They don't need elbows. What do you get cooked by
an elbow? No, thank you? Straight onto the band. Oh yeah,
we've got machines for them to breathe through. It's fine. Yeah.
So this all brings me to the very sad story

(26:55):
of viox. Near the end of the nineteen nineties, Mirk
went to the FDA to get approof for by Ox,
a pain killer meant for patients with arthritis. They believed
it was superior to older pain killers because it had
fewer gastro intestinal side effect so they're arguing, like, this
is a safer pain killer for people with arthritis. To
support their case, they presented the FDA with eight studies

(27:15):
which had a grand total of fifty four hundred total subjects.
So that is well under an average of a thousand
subjects per study. Right, that's not a lot of people
to prove that your for for for number one arthritis
is very common, right, A ton of people need medication
for arthritis. That's not a shipload of subjects to prove
that a medication is safe, right, that it really is not.

(27:38):
In November of nine, they asked the FDA for approval.
They seem to have realized their case that it was
safer rested on pretty thin ground. So as they're going
for approval, they launched the Box gastro Intestinal Outcomes Research Study,
or VIGOR. This study would have more than eight thousand participants.
So that's good. That's almost twice as many participants as
they've had in total and all the other study. Now

(28:00):
we're starting to get you know that that that could
establish a broader base that to to show that this
is science here. So but this is after they start
this big study, after they've approved, or after they have
filed for approval with the FDA, and before the VIGOR
study is finished. The f d A approves by OX
in May of nineteen ninety nine off the strength of
those small studies and nothing else. Fucking roll the dice.

(28:24):
What do you need, right, it's their own Fuck them.
VIGOR doesn't report its first results from the study until
October of nineteen ninety nine, and they were promising VOX
patients seemed to have fewer ulcers and less bleeding than
patients taking the proxen, which was the kind of standard previously.
But then in November of nineteen ninetnine, things started to turn.

(28:46):
And I'm gonna quote from NPR here. At the second
meeting of the Vigor Safety Panel, the discussion focuses on
heart problems. As of November one, nineteen seventy nine patients
out of four thousand taking bax have had serious heart
problems or have died, compared with forty one taking the proxi.
In the minutes of the panel's November meeting, note that
while the trends are disconcerting, the numbers of events are small.

(29:06):
The panel votes to continue the study and to meet
again in a month. And this would have been fine
if the medicine hadn't already been out Right, If you're
just doing this research, sure, this is what happens. Right,
if you're studying some number of people that you test
medications on are gonna die. It's going to happen. For
you can't get medication and not have that happen from
time to time. In a by deal world, you would

(29:27):
not start selling it in mass until you had concluded
this research. We finished finished the project and then decide
whether or not the public can have it. So, in
December of nineteen nine, the Safety Panel has what will
be its last meeting. They're told that as of December one,
nineteen nine, the risk of serious heart problems in death
among BIOX patients is twice as high as the approxim group.

(29:48):
So no, it's not a safer It is twice as
likely to kill your ass. But your stomach feels better
when you're dying of a heart attack, Yeah you do,
you tell me, feels better as you as you fucking
dropped to the ground. Now, the research board monitoring this,
like safety board monitoring the study, decides to continue on,
which is a questionable decision in of itself, right, Continuing
the study at this point is like, well, but it

(30:09):
kills twice. Maybe that's all we need to know about this.
Bring in a thousand more guys. Let's just let's just
be sure. Let's run through some more of them. Come on,
So they did tell merk like, this board is like,
you can keep doing the study, Um, but you should
develop a plan to analyze the cardiovascular results of the
study before the study ends, right, so that you can

(30:31):
actually determine really what the effect on people's hearts is
as soon as the studies over, because we're seeing some
stuff that's concerning, and Mark is like, no, we're not
gonna do that. Um, we're gonna We're gonna wait, We're
gonna let a couple more studies get done within another
couple of years and then we'll see if it's bad
for people's hearts. And the safety panels like cool. That
sounds cool too. We wanted to do it now, but

(30:52):
it sounds fine to do it later or never. Oh no,
I never looked at it like that before, But thank
you for opening our eyes. That will just not do
with the thing. Funnily enough, Matt. The head of that
safety panel was a guy named Wine Blatt, who also
served on an advisory board for Merk, owned seventy two
th dollars in Mark stock, and worked as a paid
consultant for Mark. Yeah, he seems like he seems unbiased.

(31:15):
That's a legic guy. That's a that's a legit dude.
How would you like it if I read your resume
every time you're advocating for things that put money in
your pocket? H Yeah, Now the company pushed the can
down the road. And sold by Ox for nearly two years.
In January of two thousand two, epidemiological studies started coming
out that warned that biox was giving people heart attacks

(31:37):
and strokes and huge numbers. That's January. Nothing gets done
until September, when the weight of evidence is so high
that Mirk begins to withdraw their drug from the market.
And it's still being sold until I think like two
four to a lot of people. Jesus. By the time
they finally get it off the market, twenty million Americans
have taken it. Now, the Lancet estimates that thirty eight
thousand people at least died from taking via x. That's

(32:02):
a pretty good yeah, they got ked now, this estimate
is likely optimistic. Dr David Graham was a scientist at
the FDA for more than twenty years when he started
speaking out about bi ox, and he's actually still working
for the FDA when he begins doing interviews about how
this happened. Here is a right up on him from

(32:22):
Fraud Magazine. Quote between nine and two thousand four and
estimated twenty million Americans took by Ox, eighty million worldwide,
said Graham. The recipient of the two thousand five Cliff
Robertson Sentinel Award at the recent sixteenth Annual a c
f E Fraud Conference and Exhibition. We've estimated that up
to a hundred and forty thousand patients who took BIAX
suffered heart attacks. Of this number, sixty thousand died, said Graham.

(32:46):
Um Yox as a poster child for what's wrong with
the f d A and why I believe FDA reform
is so urgently needed. And if Dr Graham's calculations are correct,
if sixty people died from biox, that's too box killed
more Americans than Vietnam, like holy shit, right, and based

(33:07):
on just like who tends to get arthritis? Most likely
a number of the people had killed probably survived Vietnam
only get iced by biox. They got marked by biox.
They lived through a pungi stick trap. But they couldn't
make it through the new f d A. Well, you
lose to the Vietcong and then you lose to Mark

(33:30):
sucks Merk and the Vietcong shaking hands with killing killing Americans.
So yeah, um and Dr Graham has since claimed that
the f d A not only did they were they
lax and allowing this to happen. They actually took direct steps,
he alleges, to stop scientists from speaking out against the

(33:52):
drug before it could be approved. In November of last year,
Graham testified before the Senate Finance Committee that the FDA
had silenced him and his call leaks from reporting on
the risks of Box and other drugs. The FDA has
let the American people down and sadly betrayed a public trust,
Graham said during his testimony. He alleged that because the
FDA is unduly influenced by the pharmacy industry, it is

(34:12):
incapable of protecting America against another Box. We are virtually defenseless.
That's good. Yeah, that's nice to know, you know. Yeah,
it's good to know that they you know, they started
off good, but this is yeah, they've they've fallen into
the lava at this point, you know, there in the suit,

(34:33):
they're choking people to death. Yeah, there's fingerprints all over
their helmet. If you if you watch the high res
versions of the original movies, because they didn't expect TVs whatever,
get that good? Yeah? Yeah, yeah, it was supposed to good.
So this is a claim that the America is defenseless

(34:55):
because the FDA is fundamentally compromised by the pharmaceutical industry.
This is a claim that does is there fur their
focus to do that. We're gonna have to turn back
to the story of a drug. You might be a
fan of. I certainly am a fan of our old
buddy oxy code. Oh yeah, now, I love me samopi.
It's right, but we have to acknowledge they're a problem

(35:18):
for the country. There a problem for me. Yeah, yeah,
I can no longer part that is a problem for
me that I had had couldn't after I left from
Central America. Yeah, oh god, it was pretty fun just
being able to pick up a bottle of liquor and

(35:39):
a box of code ow like on the same trip
that I got my tortillas. God man, those are the
day you know. I for years as an addict, I
would dream of going to a place where I could
just get over the counter like morphine and whatnot. And
I mean, I do think that is how it should work.
And I think it not really a problem if you

(36:00):
were not getting millions of people hooked on opiates telling
them that it's going to manage their pain, when makes
the pain much worse than like makes the problems long
term much worse. Oxy OxyContin is one of the most
evil things in the world because of the fact that
it uh it sucks like it's not it's not good.

(36:21):
It's it's not like morphine, which has like into some
liquid morphine of fucking Now the language these actually, you know,
feel good. They will destroy your life by the whole share,
of course, lots of things will. But what's what's even

(36:41):
more evil about oxycontent is that like this, they got
people hooked on an opiate that sucks and better than content.
But like, yeah, that we're now we're getting into the
weeds of which ones are good and which ones are bad? Um,
all of them are better than fucking coding, which is
trash the worst and you cannot ivy uh, you can't

(37:04):
shoot up Cody and just let let you guys know that.
Don't even go through ANIFL access. I learned that the
hard way. I was blind for sixty seconds. Anyways, that's
the good stuff you brought me on for this one.
We're both fans. But the opiate crisis is obviously a
massive titanic tragedy that has caused um maybe more damage

(37:26):
than almost anything else to particularly Middle America UM and
we've got we did a two party unproduce pharmaceutical UM
in the Sackler family who profited off of this primarily.
But now it's time to talk about the FDA's complicity.
But before we do that, Matt, you know who else
is complicit? And you having a good time? All the

(37:47):
sponsors and products, that's right, all conspiring to make you happy.
Hell yeah, and and to push oxy codo you know,
yeah for sure? All right, we're back back maybe yeah right.

(38:13):
I just want to point out I am twelve years sober.
For anyone out there, for anyone out there, it was
just like I should try that lot. It has been.
I always had a rule. I would always take it
to an honestly problematic degree when I was in places
outside of the country where I could get it. I've
always had a rule where I I do not ever
purchase it in the United States. Never have, never will.

(38:36):
Every now and then, maybe theoretically a friend has surgery
and winds up with some extra pills and stuff. But
like I, it's I've seen it's it's too it's actually
like pretty fucking horrible. Yeah, I don't have that ability.
You're like a fucking superhero to me. I can't. I
got addicted to hookah after I got clean. Straight up, Yeah,

(38:57):
I got addicted to stuff. I can't help it. I
know that if I were to let myself let it
be anything but like a vacation thing, I would immediately
have a problem and it would destroy my life, right yeah,
because I have had problems with other substances before to
the point where I'm like, I, I can see you
in the rear view mirror, you know. Yeah, it's always
doing push ups in the brain. Ready, fuck your party.

(39:19):
That is how it works. Um, So let's talk about
the FDA's complicity in the opiate epidemic. In two thousand nineteen,
a state court in Oklahoma tied quote false, misleading, and
dangerous marketing campaigns by drug manufacturers to quote exponentially increasing
rates of addiction, overdose deaths, and baby is born exposed
to opioids. This is yet another damning black mark on

(39:41):
an industry whose executives should all be flung into the
sun via catapult. But as this right up from the
Journal of Ethics of the American Medical Association argues, quote,
the fact that opioid manufacturers disseminated false claims regarding the
risks and benefits of opioids for the past twenty five
years points to a dereliction of duty by the U s.
Food and Drug Administration, the f REAL agency charged with
regulating pharmaceutical companies. The FDA's regulatory failures with respect to

(40:04):
opioids have not gotta noticed. In two thousan seventeen, the
President's Commissioned on Combating Drug Addiction and the Opioid Crisis
found that the opioid crisis was caused in part by
inadequate oversight by the Food and Drug Administration, and the
National Academy of Sciences publicly called on the FDA to
overhaul its opioid policies. Last year, a former FDA commissioner
rebuked the agency he had previously led, saying on the

(40:26):
television program Sixty Minutes that the FDA it was wrong
to allow the promotion of opio d s for chronic pain.
Maybe a little late on that one, buddy, You know,
better late than never, right, you know that? In this case?
Really that's that's kind of like going drunk driving killing
six people and then getting on the news and be like,
you know what, drunk driving people shouldn't be doing that. Yeah,

(40:46):
it's bad. It's bad. It's like drunk driving and killing people,
hundreds of thousands of people for decades and hundreds of
thousands of people, wiping out entire towns and then just
going on TV going you know, it's bigger than just me. Yeah,
this is really a systemic problem because the roads I

(41:07):
use are everywhere to drive through neighborhoods. Yeah, if you
think about it, the taxpayers just as part of this,
you know, you with the making roads mean, with the
drunkenly driving through intersections and hitting groups of children, killing
up for the bus. You know, everybody's a part of
that bus driver stopping for those kids is a part

(41:27):
of this. You know, no one's hands are clean. Nobody stands,
So let's stop playing the blame game. You know, why
don't have to blame people every time I kill six
hundred thousand Americans. So you might expect all of this
potent criticism from like again the president pretty big names
saying the f d A has a problem with the
way it approves opioids. You might expect that to lead

(41:49):
the sub changes. But FDA policies for approving and labeling
opioids remain basically unmodified. As the Journal of Ethics write
up notes, the agency has refused to undertake a root
cause analysis to determine what regulatory errors contributed to the
opiate crisis. Instead, they've closed ranks and sought to defend themselves.
When Senator Maggie Hassan criticized the agency, the FDA Drug

(42:11):
Evaluation Director responded by claiming the agency had properly enforced
the Food, Drug and Cosmetic Act when it approved produced
new extended release oxycodone in Now that's a lie, Matt,
not just because it turned out to be bad, but
because they broke the law when they approved it. If
they had followed the law, the pills would have been
listed as having a narrow indication. Um, it's kind of

(42:34):
what we talked about the schizophrenia mids. This should be
used in a few specific conditions, acutely right, I only
be prescribed in limited duration for specific issues. Instead, the
drug received a broad indication, which allowed perdue to be like, oh, yeah,
this is good for back pain. You take some of
this ship Ye, you got a slight headache? Yeah, pull up,

(42:56):
pull up your car, we'll fill your trunk. Well Senate
direct to your house, dude, don't worry about don't worry
about it. Yeah, it's it's so fucking evil because it's like,
you know, chronic pain is a thing. Are incredibly useful
for treating people with chronic pain, and there are people
out there who do need it, and and so it's

(43:18):
like I'm not one of those people's like oh, putes
are all bad and whatnot. What's fucked up is to
make it into something that you would take, like you
would give it out, like it's fucking Highland. All need
it for chronic pain, most kinds of long term pain.
There's better ways to deal with it, and like you
don't actually solve that. You can actually make it better
if you go into like therapy and stuff and you

(43:39):
aren't medicating it away, which leads to it's yeah, there's
we talk about all this in the Sackler episodes. Um
so I'm going to quote from that a m A
Journal of Ethics right up again to talk about like
how illegal it was for the FDA to give this
broad approval. And it doesn't too face with evidence that
opioid prescribing had risen beyond levels that could be clinically warranted.
The FDA convened an advisory committee meeting of tin outside

(44:02):
experts and asked if the broad indication on opioid label
should be narrowed to prohibit marketing for common chronic pain conditions.
Eight of these experts had financial ties to pharmaceutical companies,
including Perdue, and advised the FDA against narrowing the indication.
An opportunity to reign in over prescribing early in the
crisis was lost, and by two thousand thirteen, enough opioids

(44:22):
were prescribed to provide every adult in the country with
a full pill bottle. That's so funny. So it's ridiculous
how many fucking opiates we flooded in, Like the fact
that we have a bigger problem with opiates now than
when you could buy morphine at the drug store. It
should say something. It does. I'm sorry that it says something.
It's like it's one thing to have it like available

(44:45):
over the counter, and people discover it and they are
able to take it. It's problems some of them will
if your doctors you have to take this forever. Now,
this is great for you to take forever, and then
you get horribly addicted, and then the doctor says, actually, no,
we found it. It's bad and you can't take it anymore,
and then you wind up buying fucking heroin, like exactly, exactly,

(45:06):
man um. Yeah. Now, the Food, Drug and Cosmetic Act
requires that adequate and well controlled studies be conducted before
products can be approved as safe and effective. The FDA
generally requires two randomized trials demonstrating efficacy for approval. There
are a lot of problems with this process, but it
was not even followed in the case of oxycodone. They

(45:26):
approved oxy for chronic pain based on a two week
clinical trial and osteoarthritis patients. Yeah, that should be enough time.
People don't live longer than two weeks, do they. It
takes me twenty four hours to realize whether or not
or opiate is good or not. I just try it out.
I have a human test subject. So yeah, you take it,

(45:48):
and you're like, yeah, that's good. Give it everyone, Give it.
Give it to every man, woman and child in the Midwest.
Oh my god. You know what empty the swimming public
swimming pool with pills just failing with oxy is extended release.
We'll just dive into it like a fucking junkie. Scrooge McDuck.

(46:08):
So for the next twenty five years is the opiate
crisis sparked off and then deepened? The FDA continued to
approve new opioid formulations for chronic pain via the same
shoddy lack daisical controls, and two thousand six the agency
moved to a new methodology for conducting efficacy trials on opiates.
This new methodology, enriched enrollment randomized withdrawal, or e er W,

(46:29):
became their primary method of determining evidence of opioid efficacy
for chronic pain. E er W trials are not standard
double blind, randomized controlled styles, and here's the A m
A again. In an e er W trial, Prior to
randomization for a double blind phase, all subjects are made
physiologically dependent on the opioid and a fourd to six

(46:50):
week open label phase. Then only the patients who tolerated
the opioid and found it helpful during the open label
phase are randomized to remain on the opioid or switched
to a placebo. Critics of vra W have have correctly
described this methodology as cooking the books for two reasons. First,
because only patients who tolerateed the opioid and found it
helpful are allowed to proceed to randomization. The study is

(47:12):
not representative of the general population and the results cannot
be generalized to clinical practice. Second, because daily use of
opioids causes physiological dependence, efficacy studies are skewed in favor
of the subjects who remain on the opioid. This is
because opioid dependent subjects who are switched to placebo experienced
opiate withdrawal symptoms, including increased sensitivity to pain. Moreover, switching

(47:33):
opioid dependent subject to placebo renders the study not double blind. Boy,
all these addicts really like opius. It seems like it works,
you know. And here's how you know it works is
when you stop giving it to them, they get fucking weird.
They don't like it at all. It must mean it's helping. Crying,
it's helping. Clearly you gotta take it or else you

(47:53):
start did they just start crying and being in pain? Man,
that's weird. Nanatin alcoholics says it makes them a better driver. Exactly. Man,
oh I love that. That is like such a such
like an evil thing to do. It's really fucked up, right,
So evil, Like the amount of people who like just

(48:14):
got addicted to this thing because they were just like,
you know, cooking the books on this test too and
fucking But I would have loved to have been a
part of that study. Yeah, yeah, I just check it
out a little bit. I don't know. So the a
m a Journal of Ethics article that blames the FDA's
decision to rely on e er W as a consequence

(48:36):
of their clothes, some would say, incestuous ties to the
pharmaceutical industry. It turns out that that the decision to
use e er W had been based on a series
of private meetings between FDA officials and pharmaceutical executives hosted
at a conference called Impact with two ms, it's an acronym.
You don't need to know what it's for. The drug
companies that attended Impact each paid thirty five thousand dollars

(48:59):
to meet directly with FDA staff. So they have a
big meeting where these guys pay, and money goes to
the FDA officials who were invited guests. I don't see
oh that's a problem, Robert. I don't see that as
a conflict of interest. No, that's totally normal. It's like,
fucking listen, it's it's a donation. Yeah, you know, and
if you don't want to donate, you don't get access. Now,

(49:22):
when this information dropped, there was a lot of complaints
about this is being like, oh, it seems like rank
crony ism is why this is the method by which
we determine whether or not opiates are good. Despite all this,
the FDA continues to rely on E er W for
approving opiates, and as the yeah, yeah, I know, they
ain't changed that ship, at least not as of the
writing of that article. Yeah it's cool, it's good ship.

(49:43):
So as the a m A Journal of Ethics details,
the crony ism does not stop here. Quote. For example,
the two principal FDA reviewers who originally approved produce oxycodon
application took both took positions at Purdue after leaving the agency. Hey,
that's just a cool. Yeah, that's just a weird kinky dink.

(50:04):
Listen your email and all your ex contacts and you're
just like, hey, do you have like a job with
a fucking seven figure salaries here? And I don't want
to like go in you know, if that's possible, Yeah,
if you could just you know you could. I'll write
it off of my taxes as hush money. Yeah, I'm

(50:25):
gonna continue that quote. Over the past twenty years, several
other FDA staff involved in opioid approvals also left the
FDA to work for opioid makers. Last January, the head
of the FDA's analgesic division retired from the FDA to
start her own consulting business, which promises drug makers help
to successfully and efficiently bring your products to market. With
more than thirty years of experience at the f D.

(50:47):
A but that's fine, that's legal. You know, it's good.
I mean, you know, you get the inside track on
how to get people opiates. Yeah, And obviously this is
how the whole government works, right, But it didn't used
to be how the FDA works. And I should note
that the revolving door, as this article states that states

(51:07):
the revolving door between the FDA and the pharmaceutical industry
is not just opiates. Two eighteen study found that eleven
of sixteen FDA medical reviewers involved in approving twenty eight
products now work for the companies whose products they regulated. Wow,
it's good stuff, right, it's fine, it's it's great. I
mean it's just it's so blatant. This is why, like I, oh,

(51:30):
this is every time I came on this podcast. Man,
I lose faith in humanity. But some version of this
would still be happening if they'd never moved to a
fact where like the f d A is half funded
by pharmaceutical company applications. Right, correction, it's endemic. But this
I think that really sped up the process. It's had
an impact, right, it's very clear to see in the data. Um,

(51:53):
And it's now the relationships are built on money already,
and you have like people, you know, it's one thing
to spend earty years like being completely fucking government funded
and just telling people no, no, no no on their
applications not you know, fucking I have no financial ties
to them. But now you have like kind of a
sugar daddy that who's going to be courting you and

(52:13):
has been paying my salary. You know, why shouldn't I
go to work for the right? Why is this any different?
And I know this guy, know, Roger over at fucking Fiser, Like,
wouldn't I work there? He's been paying me since fucking
day one? Yeah? Yeah, And the f d A is
complicity with both the opioid crisis and the vi X
disaster have the highest definite body counts for sure, um,

(52:35):
but some of the ways that they've really that the
FDA is really fucked up are less obviously deadly, but
still very unsettling. Now, if you'll remember, the whole reason
we have an FDA is because Harvey Wiley was pissed
that all kinds of foods and drugs and quack tears
were being shoved full of random horrible ship that was
not listed in the product, and people didn't know what
they were getting, right. That's why we got an f

(52:56):
d A. Is a bunch of people, Harvey Wiley and
others were like, this seems bad. The main, the primary
goal of the f d A was to make sure
people know what the funk they're putting in their bodies,
right at the end of the day. That's the number
one reason we have the FDA, to know what you're
putting in your body and what it does to you.

(53:20):
G R a S is an acronym that stands for
generally recognized as safe. This is a category the FDA
created for food additives that might be stuck in new
products without being specifically approved but that don't need any
specific additional approval because they're generally recognized as safe. Now,
this starts again from a pretty reasonable place. It's so
that like, if you're making a processed meat, you can

(53:40):
add vinegar or salt to it, and you know if
to like get approval from meat with vinegarrants because we
know what vinegar and salt do? You know what the meat?
It's fine, you can stick it in there right. Um,
So I'm gonna quote from NPR again quote. Over time,
companies have found that it's far more efficient to take
advantage of the exemption to get their products up on
shelves quickly. Some of these products contain additives that the
FDA has found to post dangers, and even ingredients the

(54:01):
agency has agreed r g R g r A s
are now drawing scrutiny from scientists and consumer groups that
dispute their safety. Critics of the system say the biggest concern, however,
is that companies regularly introduce new additives without ever informing
the f d A. This means people are consuming foods
with added flavors, preservatives, and other ingredients that are not
reviewed at all by regulators for immediate dangers or long

(54:21):
term health effects. The vast majority of food additives are safe. Somehowever,
have proved to cause serious allergic reactions or other long
term health effects. Now a good example of this would
be micoprotein. This is a kind of fungus product used
to add protein to vegetarian foods. It counts as g
R A S, but there's a bunch of lawsuits right
now that allege a significant number of people have had
really negative allergic reactions to microprotein, some of them anaphylactic

(54:45):
shock um, which is mean nobody should take it, but
it means like it's shouldn't be listed as generally recognized
as ship as safe if a lot of people have
like allergic reactions to it. And flexus is incredibly dangerous. Yeah,
and the the FDA did eventually revoke it's g R
A S status in two thousand eleven, but a lot

(55:06):
of people had to get sick. Person. It's kind of
an example of how like you can just kind of
shoehorn this stuff in. It's a loophole and it's not
watched that closely. Probably the most serious problem with though,
is with all the weird preservatives being stuck into foods. Again,
most are benign. Most preservatives are, as far as we know, benign.
But g r S exemptions mean that we don't really

(55:26):
have data on how a lot of this stuff affects
children differently, or whether or not it builds up in
the body. And I'm not trying to be like hippie dippy, like, oh,
no preservatives in your food. Man. Stuff is necessary, but
we should know what it does, and we shouldn't call
it safe or put it in everything unless we have
really good data that it's safe. Like you know, we're
going backwards here. We already established we want to know

(55:46):
what's inside. Like whiley, I'm not against preservatives or even
chemicals and food, I eat all sorts of chemicals. We
should know what they do. Just like it's like it's
so important. Yeah. I found a recent study by the
Environmental Defense Fund that looked through eight hundred and seventy
seven g r A S notices by the f d
A and found that only one of them was for

(56:08):
an additive that the manufacturer had done a cumulative effect
study on this is like determine whether or not it
builds up in the body and could be harmful. One
out of eight hundred and seventy seven had they had
had this done. And this isn't optional, These are required
by law. You have to do this. One out of
eight hundred and seventy seven that the FDA had approved
had actually done this, As the e d F notes quote,

(56:28):
We found no evidence that the agency either recognized this
single attempt to follow the law or had objected to
the emissions and the eight hundred and seventy six other notices.
They're just sucking Robert stabbing this ship. They don't give
a fuck. Yeah, they don't even force them to pinky swear.
They're just like they get money for every one of
these applications. You know what. You don't want people to
not send in an application if they haven't done the research.

(56:50):
You want that fucking box. She's baby Jesus. Well, you
know that's uh, it's good, that's fine, It's it's all
really again, this is like anti f DA and that
there's huge problems with the FDA, But like we need
an f d A what it's called, But we need

(57:11):
an agency doing that, right, Like that's why we started
with like plamide. This is an absolutely necessary part of
any society, vaguely similar to the one we live in.
But we've we've broken it, We've allowed it to become broken,
and it it doesn't work great, and it's a really
dangerous thing to have as a corrupt organism. And again

(57:32):
there's like as that we we quoted from that that
FDA researcher who was like, you know, has been howling
about box and stuff, and it's like, yeah, it's um,
there's most I'm sure most of the people trying to
do those jobs are are fucking rad and even I'm
sure mostly people who wind up joining the pharmaceutical industry
they're not thinking like ha ha ha no, but it's

(57:53):
like they there should be a bias towards distrust and
dislike of the pharmaceutical companies by the scientists you doing
this right, Like they should be untrustworthy of them, you know, right,
I expect the pharmaceutical companies to lie about ship. That's
what they do. They're salesman, you know, they're like we
they make they fucking patent just random compounds or like

(58:13):
does that do anything. No, it's like basically just trying
out a bunch of things to see if it makes
your dick hard. And then eventually they'll just be like yeah,
that makes your dick hard. You need an agency that
takes the medication and goes like, my dick is still soft.
You can't just pay someone to be like, yeah, I
don't know enough. People's dicks got hard. You gotta know

(58:35):
that it gets you bricked up, Robert, Yeah, it's it's
you've got. You gotta know that. It allows you to
fucking lay some goddamn pipe, you know pipe. That's right,
that's right, that's what when America was great, we knew
that was what the the FDA was for. Now, yeah,
you goddamn right. Um, So I don't know, you know,

(58:57):
I I would like to have an FDA that it
does not have the problems of our current f d A.
I don't think that's too much to ask of society.
There's a lot of a lot of our problems are
kind of intractable and difficult to figure out a solution too.
But like, yeah, we should probably have like they should
probably be advocates for us and not totally wing of
the pharmaceutical industry. I mean, honestly, it's like weird for

(59:19):
us to be going backwards on such like an obvious
fucking thing. It's, uh, we don't want to drink the
poison milk, and uh, we don't want people pushing a
bunch of fucking drugs that don't work or funk up
your life. Yeah, those would be you just go back

(59:40):
to the Francis days. She was dope. Let's let's hire
a bunch of people like her and give them all
very large salaries to be distrustful of the pharmaceutical industry.
That's like their job, that's the whole job. And we
spend so much money on stupid ship. We could have
a we could have a sufficient at least sized team

(01:00:01):
of people to to to distrust the pharmaceutical industry professionally
for the price of a couple of f thirty five
yeah right, literally two less fucking you know, just jets
that that bomb Yemen, you know, Yeah, and we we
take money away from them when they let a drug
through that kills way more people than reasonable as like

(01:00:23):
you know, some side effects, and then then we're bribing
them to make sure we don't die. Exactly. That's literally
how it's supposed to work. I mean, just yeah, we
should be you know, we should be making money off
of UH, or the FDA should be making money off
of destroying these pharmaceutical agencies as soon as they fuck up.

(01:00:47):
That's what I say. Yeah, I would be sick. That's
one way to tie it. Tie it in. Wow, Boxy
sucks and suck it. Well, Matt, do you have any
plugables for us? Um? Yeah, try it. I'm just kidding. Uh.
Pod yourself a gun. Uh. The World's Only Sopranos podcasts

(01:01:11):
and the film Drunk frodcast me and Vince Vncini talking
about movies, talking about just life in general. Matt Leap
jokes on Instagram. I love you guys. Oh well, you
can find me nowhere. But I have a novel that
you can pre order, and if you pre order it,
you'll get assigned a copy. Just google a k press

(01:01:32):
after the revolution, order a book now, it will come
to you with my signature in it. That's pretty neat. Um.
We also have a live show we do on February
sevent The ticket info will be in the episode description,
or you can go do allegedly. I'll do it allegedly

(01:01:53):
in the episode description. Dot com slash pot of Bastards allegedly.
All right, Well, until next time, you know, skim the
cream off some milk, fill it up. With water, pour
some worms in there, and you know, I breakfast a
little bit of cowbrains, get some extra protein up in there.
You know, you get to gottle grains. You think that's right,